CEFENIL 50 MG/ML POWDER AND SOLVENT FOR SOLUTION FOR INJECTION FOR CATTLE AND PIGS

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

CEFTIOFUR SODIUM

Saatavilla:

Norbrook Laboratories Limited

ATC-koodi:

QJ01DD90

INN (Kansainvälinen yleisnimi):

CEFTIOFUR SODIUM

Annos:

50 Mg/Ml

Lääkemuoto:

Pdr for Soln for Injection

Prescription tyyppi:

POM

Terapeuttinen ryhmä:

Bovine, Porcine

Terapeuttinen alue:

Ceftiofur

Käyttöaiheet:

Antibacterial

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2009-09-25

Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Cefenil 50 mg/ml Powder and Solvent for Solution for Injection for Cattle and Pigs.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Powder vial contains:
ACTIVE SUBSTANCE
Ceftiofur (as ceftiofur sodium) 1g
Or
Ceftiofur (as ceftiofur sodium) 4g
Solvent contains: Water for Injection
One ml of reconstituted solution contains:
ACTIVE SUBSTANCE
Ceftiofur (as ceftiofur sodium) 50mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
Powder: off white to brown coloured powder.
Solvent: clear, colourless, solution.
Reconstituted solution: clear solution, free of particulates.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle and pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Cattle
Treatment of cattle with acute bacterial respiratory disease in which _Mannheimia haemolytica, Pasteurella multocida_
_or Histophilus somni _sensitive to ceftiofur are involved.
Treatment of cattle with acute interdigital necrobacillosis (foul in the foot) in which _Fusobacterium necrophorum _and
_Bacteroides melaninogenicus _are involved.
Pigs
Treatment of pigs with bacterial respiratory disease in which _Actinobacillus (Haemophilus) pleuropneumoniae,_
_Pasteurella multocida _and/or _Streptococcus suis _sensitive to ceftiofur are involved.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 24/09/2014_
_CRN 7018524_
_page number: 1_
4.3 CONTRAINDICATIONS
Do not use in animals previously found to be hypersensitive to ceftiofur and other b-lactam antibiotics.
Do not use in case of known resistance to the active substance.
Do not use in cases where resistance to other cephalosporins or beta